Note: Descriptions are shown in the official language in which they were submitted.
- 68478 CA 02236409 1998-04-30
~UID l'RANS~ER DEV~OE
T~h~ Al Field
This ~e~io n relates to a device and method for ~ G ~ ¢ fluid, especially for
..~in;...;,;n~ the p~~nce of air bubbles in ~ ,d pa~ al fluids, e.g., saline
5 and/or !.A..~r.~ such as blood Co
~acl~ ld of the L~ tiun
Many fluid lLa~r~ ~t~ s such as fluid ploc~ a,~i~t~ 5 r.. 1;O,, more
l~r,. ..ll~r if they can be at least partially purged of air or gas before use. A.~ itio~qlly,
some ~ r." s~ , e.g., for ~-~lll;n;~h(;l~ fluid to a pa~en~ should ...il-;~..i-,~ or
0 ~ ,nt air or gas from passlrLg beyond a certain location in the system. For example,
some illlLa~r~,Ll,UUS av) i~ ,t~ s include a drip chamber or a bubble trap to ca~uLe air or
gas so that it will not be ~ d to the patient. The drip ch-...~r can also be used
to allow the opelator of the system to ...o~ o~ the rate at which the fluid is ~ d.
For example, the Op~aLûl may obsene the drip ~~h~ kcr to ensure that the patient is
15 ~ce;~ g the liquid at a given rate, e.g., a rate of so many drops of liquid per minute.
If desired, the rate can be ch~;d and the new rate can be ,...,~.itv~d by obsG.v~ the
rate at which the drops of liquid pass through the chaLu~.
There are dLa~ac~ to conv~ ;on~l fluid LLa~Sr~ ~ LLS, especi~lly when used
to ~La~r~,. fluid at a high rate. For ~pk, during a trauma situation, e.g., when the
20 patient lCCf~;~.,S one or more units of red cells andlor saline at a flow rate of several
hU~L~dl cubic c- ~1;...- r~.~ per minntf ~ the fluid in the drip Ch --..h ~ can b XO~ foamy,
and it can be r~ lt to ple~nt ~,~Lap~ed bubbles f~om passing with the blood and/or
saline through the drip cll~-"l~ to the patient. The pl~,bl_m is incl~ since the blood
may have to be ~all..ed before t-, ~ru~iO~-, and ~aLIlPi~lg the blood causes air to be
25 1f 1P~ into the blood, m~ki~ it more "foamy~ n
A(l~lition~11y, the drip l'h~ hF~ can fill too quickly, and a high level of fluid in
the ch~mher can provide ;... -rl;~ space for a drop to folm before it co..l; -l~ the fluid
in the chamber, maldng it (1imrl11t to count drops. As a result, the op.~t--r cannot
rl~t~....;.~f the flow rate. In some ~ ;ol-~, the fluid level and/or the ple~.lce of foam
68478 CA 02236409 1998-04-30
can be such that the opel~tol is unable to quicldy d~ if blood is actually being
",;,~;~r~ ~,d.
The present iu~.llion provides for ~ iold~ at least some of the
disa~lv~-~tages of the prior art. These and other ~l~,~L~es of the present iu~e~lti~ will
S be ap~ from the des~ tion as set forthbelow.
S~ of the Iu~
In accol~ with an e ubo~ f ~t of the present i~ Liun, a fluid ~ rf ~
device such as a drip ch ~ iS p~vided that is capable of ~ r . ;~ liq!lid at a high
rate, and ~,~iilg gas, while coqlPsci~ bubbles that are le.llu~d from the liquid flow
10 path. In a more pl~,f~ d e~bo~ t the drip ch~ ~ canbe filled to a desired level
of liq~id, wL~.~m the qml)llnt of liq!lid in the ~h~ is less than the tot. l liquid
capa iLy of the ch-~..hPr~ and the G~c.aLo~ of the ~.h-...~ can observe a stream of liquid,
or drops of liquid, ent~..;.~ the chqmbPr.
Brief Descli~tion of the DldwlllgS
Figure 1 is a cross-s~l ;- n~l view of an c~.lbo l;~ n~ of a venting device
acconli~g to the present ..1~ ntion.
Figure 2 is a view of the device of Figure 1 along line A-A.
Figure 3 is a view of the device of Figure 2 along line B-B, sL~wi~g a porous
.1;.- ., for passing gas l~. ~l~uugh located in the device.
Figure 4 is a cross ~ I;onal view of the upper cl~nhf-- and the porous m.o~lillmof the device of Figure 1.
Figure S is a cross ~ ~ nal view of the lower ch-~..ke of the device of Figure
1, ~L~w~ a ~g,~ el~ for co~l~srir~ gas bubbles located in the ch~mher.
Pigure 6 is a cross ~I;onal view of another en~ ..f n~ of a ~l~n~ , device
25 accol~iQg to the present invention.
Figure 7 is a s~ h- ..~l;r view of a system for !~ .n.~ g a fluid in accolddn~
with the invention, inrl...l;u~ the ~ g device ilh.~t~ in Pigure 1.
Pigure 8 is a srh. ~~. ~1;r view of a system for ~r~ g a fluid in accol~ce
with the ill~ ~ion, in~ i~ the ~ g device ilhlstrated in Figure 1, and a fluid filter.
6~78 CA 02236409 1998-04-30
Specific De~li~ion of the Invention
In accû~l~ce with the present in.~nLion, a device for l~d~r~ fluid is
provided c~---p-;~;~ a h.)--~ co~ ing a fluid l~,se~ioi~ for gas and liquid; a vent
and a ~kg~ic;~ e~ 1 co..,...~ ;r-l;.u with the h.~ , the vent Cf~...p.;.~ a
S liquophobic porous ",~.1;,-.,. that allows gas in the h-3--~ to pass through the .n~,.l;---~.;
the ~leg~ e~ --..~ .l Cul~ a coq1PscP,r that co~lPsces gas l,~les and forms larger
bubbles that rise in a cen~al portion of the h(~u~ing, the vent and the housi~ being
cQo~-. ~ . ly ~ i to allow the gas to be vented from the h....~ . In an
embo~ 1 the vent, the ~ s;.~ elP .~. n and the h.,..~;~ are COOpe~ali~- ly
10 ~l~d~g~ to allow the gas to be vented from the h...-~ . Preferably, the device allows
id to fill the h-,--~;~ to a level that is less than the total liquid Cdpd~ily of the
hrJ..~
Typically, the device for ~ r ~ fluid cn...p. ;-~ s a flow ...~ t~ device such
as a drip ~~ha"-her that directs fluid non~ - ,l;any to a first surface of the ~1e~ .ei~
15 pl~ ~rn~ The device may also include a structure such as a cap, plug, and/or valve
capable of e ~pag;~ with the huusillg, e.g., to cover and/or seal the vent.
The present invention also provides a drip cha.n~f r CO~ ;!C;n~ a housing
inrl~ a ~ uophobic porous m~ 1m and a ~g~ e~ n~ ~1 the device allowing
liquid to fill the h....~ to a pre~1etf ...;nf~l level, or less, wilhouL con~le~ely filling the
20 h.,..~iQ~ with liquid, the ~1eg~ elc .~ coqlP~eci~ gas bubbles and folll~~g larger
bubbles that rise in the central portion of the h-JII~iQ~, and the liquophobic porous
,..f~ " allowing gas to pass from the housi~g.
In accGl~ ce with the hl~ io4 a system for ~ at least one fluid is
p~ided, the system CO~U~l~ ~g the device for l.A,.~r. ..;.~ fluid, and a C~
25 ~ui~le for ho1~i~ a fluid to be I . A.,~r. . I~d, wll.,.~,~ the device is in fluid
co...--.~ a~i~ n with the contain~. In an embo~im~nt, the device c~...l.. ;. es a drip
chqmh~r, and the system also in~hlcles a filter, e.g., a blood filter, i~osed bel~e.l a
co.~ in- ~ suitable for hol~ a fluid to be ~ r ~ .~,d, and the drip r1~an~hc~ In some
embo 1--,--~ , the system inrhlcles a plurality of cont~in~ ~ e.g., suitable for holding
30 dirf,..,~ fluids to be l~ A~ d.
The present h~e~ltion also p~idcs a m.oth~l for ! ~ ,....~r~.. ;-.~ one or more fluids
con~ passing a fluid CQ.. l.. ;.~in~ a liquid and a gas into a device cc.. l~ ;n~ a
68478
CA 02236409 1998-04-30
i~ inl~hJ~li~ a fluid l~se.~oi~ for gas and liquid; passing liquid into the housing and
g gas from the device, wl~ venting ;n~ J~5 passing gas through a li~luophobic
porous ,..e~ ." un~l the liquid collth~ the porous ...~ ..; coql~sci~ gas bubbles and
allowing the co~l~ed bubbles to rise in a cen~al portion of the ho~ , and passL~g
S liq!lid from the device. In a pl~,f~ ,d e ~,bo~ d, the mf th~ inrl---les di~,Cli~l~ the
fluid non~ E~.n;~lly to a first surface of a ~ e ell ..f nr that cs~lesc~s bubbles,
and obs~ g drops of liquid ent...;n~ the ceD~ral portion of the hn..~ , wll~,~ the
k.~ i~ is filled to a level that is less than the total liquid Cdpaci~ of the ~us~g.
Typically, one of the fluids to be ~ r. ..~ is a biological fluid such as blood or
10 a blood colll~on~,~, and e~ ..- nt~ of the method also include ~.ln,in;.i~ the
biological fluid to a patient.
Emba1;..~ .~i of the present in~ tion p~u~i~ for e~rr;.~ t ~--~t;on of gas or
air from a fluid flow path, and the present i~ n~n is par~cularly suitable for those
pal~,~lal fluid ~ ..;n;~ ;Qn plot~cols that require ~.~r.,llh~g at least one p~t~
15 fluid (e.g., a biological fluid such as blood or a blood COlll~O~) at a high flow rate
during at least part of the p~t~col.
As used herein, the term "gas" inr~ es air. In accol~c~; with the invention, a
biological fluid inclll~es any treated or u~a~d fluid ~co~ with living olg~n;~...~,
particularly blood, in-~l..tl;ng whole blood, warm or cold blood, and stored or fresh
20 blood; treated blood, such as blood diluted with at least one phy~iologi~ ~l solution,
inr~ i~ but not limited to saline, I~ ;f.~t, and/or ~ntiro~ nt sollltirmc; bloodCOl~ C~t~, such as platelet con~f--l~ (PC), platelet-rich plasma (PRP), platelet-poor
plasma (PPP), platelet-free plasma, plasma, fresh frozen plasma (~), co~ ?o~
obt~i~d from plq~nq packed red cells (PRC), !.~n-:l;. n zone rnqtPriql or buffy coat
25 (BC); blood products derived from blood or a blood CO~o~ s~ or derived from bone
~ 'V; red cclls sep-~ from plasma and l~ ~ndf~l in a physiological fluid; and
plqtPlPtC ~,p~.~.l~ from plasma a~d l~ . nd~d in a physiologlcal fluid. The biological
fluid may have been treated to remove some of the lcu~oc~s before being pç~ed
accoldillg to the L~.,~ion. As used herein, blood ~ or biological fluid refers to
30 the C~ fll~ rle~-;l~d above, and to similar blood p~ or biological fluids obt~i~ed by other means and with similar p~pe~lies.
A "unit" is the ~lu~ity of biological fluid from a donor or derived from one unit
68478
CA 02236409 1998-04-30
of whole blood. It may also refer to the qu~~ drawn during a single donation.
Typically, the volume of a u~it varies, the amount ~I;rr. ;.~g from ~onq~ion to donation.
Multiple units of some blood col~ ts, particularly pl~t~ and buffy coat, may be
pooled or col,.b~d, typically by Cu~ ~g four or more units.
S Each of the colllpon~ of the i~ lion will now be d~ ;bed in more detail
below. Like Co~ o~ts have lil~e l~,f~ ce ....~
In the ~ a~ c~bo~ .n i~ fd in Figures 1-6, device 100 inrl~ e~e a
h~)..ei~ 14, having at least one iDlet 1 (Figure 6 shows an ~ ;r)n~l inlet 1') and an
outlet 2; a lumen or central portion 21 for fluid flow ~.~n the inlet and the outlet; a
0 ~cg"C-c;~ Cl~ d 50; and a vent 3 providing a gas flow path.
The di~g~ ng el ~.. nl 50 coa 'S small b~ l)bles into larger l,~bks that rise
into the central portion 21, and COlllpli3eS a porous ~llu~;t41~ having a first surface SOa
and a second surface SOb. The vent 3 c~...p~;~çs a porous ..~ 10 that allows gas,
but not liquid, to pass from the lumen or central portion 21 ~ uugh a port 4 into a gas
p~sageway 5 and through a port 30. Typically, porous ",,.l;.. 10 is located in the
hvu~i~g 14, and h~ a first surface 10a facing the inlet 1 and 1' (Figures 1 and 6), and a
second surface lOb facing the outlet 2. Preferably, porous ,..P.l;..n. 10 has a portion of
the first surface lOa near or ~dj ~c~nt to port 4 of gas p~sageway 5.
Typically, as ~ t' ~1 in Figures 1, 3, and 4, housing 14 in-~hl~les a first
portion 16, having an i~let 1, and a groove 29. The first portion 16 also in~ Ps a
nipple 22 having a port 23 leading to central portion 21. P~ef,.ably, the nipple n and
port 23 direct the fluid non~ e~ ;ally toward the first surface 50a of the ~P~ ;ng
el~ .l 50. If desired, the hvusing can be ~ang~d to allow liquid to enter the ce~al
portion 21 in the form of dlùpl~.
As i~ t~ in Figures 1 and 5, hu~mg 14 also in~ dc5 a second portion 18
having an outlet 2, and a lip 19. In l:he ~ bodil l~ shown in Figure 1, the first portion
16 and the second portion 18 are sealed to form a first chqmh~-r 15 and a secondchC .. l~ ~ 20 enco~ya~ lumen 21 and porous ",.'.l;.. 10.
Preferably, as ill- ~ ~ in Figures 2 and 3, porous .n~.l;.. 10 iS ~nmll~r in
shape, and surface lOa faces a series of ribs 25, 26, 28, and/or c~ n~lc 24, 27 in the
first portion 16. Typically, in those e.~,bo~ ..- nl~ having an amlular porous ,..~-1;- -,. 10,
the ribs 25, 26, and 28, and the cl~ n~lc 24 are gen~lly c~ nl . ;~.. In the m~ t~fl
68478 CA 02236409 1998-04-30
emho~limPnt first portion 16 also in~ludes radial c~nnflC 27.
Figures 7 and 8 illllc~te embo 1;... ~~1~ of qpical s~:itL~s 500, 501, utili7i~
device 100 during the ll~r~ of at least one fluid (e.g., a p~lltelal fluid) to a desired
~c~ ;on In these ~ c~ embo~ t~, the system in~ 5co~ ;nf~ 200 and
5 200' for holding one or more fluids such as pa~,al fluids, ~1~ the co.~ are
in fluid co.. ~ n, via cr~lu~ such as cQI.~h~ 201 and 210, with the device 100,
and the destination of the fluid, e.g., a patient. Figure 8 shows system 501 i"-l...1;.,~
~d~lition~l c~ 219 and 220, a filter 300, e.g., for filtPriT~ a p~. ,lt~,.dl fluid before
";..;~ it to the patient, as well as an ~ n~l vent 101 co...~ a gas inlet
10 and/or gas outlet, wL~,e~ the vent 101 ;~~r~ f~ s a porous ,,,f.l;,.." suitable for pa~s.n~
gas 1~ JU~.
The system also in~ln~e,s at least one, and more preferably at least two, flow
con~ol devices 400 and 400' such as cl~mps. Typically, the system, which can be open
or closed, in~l~ules one or more conl-~c~.~. For P~mple, in some embo~l;...r~ , the
15 system in~hl-les a "spike" for con.-f cl ;n~ a conduit to a cO..I;~il.f ~. Of course, in other
embol;---- ~-l~, CO~ O~ t~ of the system can be connf~h~ in accGl~ce with other
protocols known in the art, e.g., via sterile ~
It is i~ f~ that the present i~ ion is not to be limited to the above listed
co~ one.lls of the system. For eYqn~rl~P, the system may have CO~.lt~ such as, but
20 not limited to, co...~Pcto,~, ~q.~ itit~nql co~ u s, ;.~jf~-l;.~n ports, and additional vents
such as gas inlets and/or gas outlets.
As noted above, the embo~ of the device and system provide for ~enLillg
gas, and vent 3 pl~u~ides a gas flow path, ~l~,~ l gas, but not liquid, passes ~ u.u~ a
porous ".f.1;,~." 10. Typically, the gas passing Ihluu~ the porous ".f.1;~,. 10 passes out
25 of the device. A~ itiorqlly~ a deg~cc;i~g elF ..~ 50 provides for coqlesci~ gas such
that smaller gas bubbles co~lesc~ into larger bubbles. As liquid flows through the
device, the larger bubbles rise into the cer~al lumen 21. Thus, since gas bubbles are
co-q-lP~ the liquid that flows lllLUU~ the outlet 2 of the device 100 is ~b~t~.l;ally
deR~ csed In an e,ubo 1;-..~ some of the coqlPsced bubbles flow through the vent 3
30 and pass to the ~AL~"ior of the device.
The d~g~cs;..g rt -- d 50 can be f~cl~ nt~ from any mqtrriql that causes small
bubbles in the liquid to coql~sce and separate ~om the liquid. In a pl~f~,lcd
68478 CA 02236409 1998-04-30
embo~ the ~ ;~ P~ co~yl~s a porous ~LIu.;~ such as a porous foam
or sponge mqtr~ In ~ ;on, the deg~c.~;n~ P1~ n may be treated with an
anti-fodl.liQg agen~ to aid in breaking down the film ~.~._.,n bul)bles. Suitable agents
include, but are not limited to, a coll.~ d of cilironP and silica, such as Me~li
5 A~iroa.ll A, available from Dow Corni~ Mfg. Co.
The ~5~ e el~ t can have any ~uitable co~ o~, and is preferably
di~po~ in the second portion 18 of the device 100, e.g., in the second rh ~ f - 20 and
e~ ly across the fluid flow path from the inlet(s) l, l' (Figures l and 6) to the outlet
2.
Porous ll-P-l;----- 10, which is typically CQ-~ - ;~,s a membrane or film, inrl~ s a
ophn~bic portion such as at least one 1iT~ophl bic porous c1~ or layer. The
uol)hobic c~ or layer allows gas to pass lllUU~, but is not wettable, or poorly
wettable, by the liquid being ~ r. .~d through the system.
In accol~e with one e"lbodhl~ t acco~ling to Figures 1-3, the porous ".~.1;..."
15 lO is disposed in the h.J..~ g 14 to vent gas through gas passag.,~ay S until the m~linm
is collla~;~d or co~e~d by the liquid being l.,.n.~r .,~d. Liquid does not snb~ lly
pass through the porous ...~-1; -... 10. Once the ",~.1;..." 10 is co~"ed by the liquid, the
device 100 has been filled to the desired level, wi~ ul ove~i~ Under typic~l
con-1;l;on~ of use (e.g., a-1n.;n;~ " to a patient), a volume of gas will be present in
20 ~e i~,ior of the h.,..~ 14, and the liquid level will remain at the desired level, or
less.
A variety of mqt~riql~ may be used, provided the l.~ ; plO~ S of the
porous ,.,~.1;..." 10 are ach.e~d. These p~pf ~ S include the nfcess~r~r s~ to
handle the dirr~ S~S en~U~nt~ ~,Xi in use and the ability to provide the desired
25 pe~m~-qbility willlùu~the appli~qti~n of c;Aces;~ivc pl.,~ ul~,. In one pl~,R"
embo ~ f~ the ...P...klAnr, has a high surface tension and a high water inL~sio~
P~,.
Sl~itq-ble starting ~ h - ;~lc include ~ l.elic polymers in~ li~ poly~mi~les,
pol~ , pol~ul,rms, particularly poly~ lene and pol~ l~l~.llene, p~rfh~ t~l
30 polyolefins, such as pol~ of~;l~lene, polysnlfon~s, polyviu~lidcn~ difluoride,
polyacrylonitril~ and the like, and co...~ le ~,s of polymers. Within the class of
pol~,....;~les, ~ui~ble polymers in'~h~de~ for ~ ~-..pl~, pol~ n.- :h~lene ~ a...i~P"
-68478 CA 02236409 1998-04-30
poly-~,apro!~~t~m, poly~ ;l~lene seb~ e, poly-7- ~-;nf h- ~t!~ s~ e,
poly~ lene ~-lip~.,,iflr (nylon 46), polyl. ~; -- - lhjl~ P~"~;~1C;, and
pol~h ~ a~l;p~ P (nylon 66).
Typically, the porous ,.,~;~.. 10 _as a pore size of about 5 ~ -,t~ ~ or less,
5 more p~,f~ .. bl~, about 3 ~..,lvl~l -t~,~s or less, even more preferably, about 2
llPic~..~-,t~ -~ or less. In those embo l;,n. .,t~ ;".-1.,.1;"~,, -h,.;,.;.~t. . ;~r fluid(s) to a p~tif~nt
the ",.P.l;~", 10 typically has a b~çt~ l b~ rin~r pore ~hu~ , to preclude b ~r-teri~ from
t,,~t ~ ;~p~ the system through the vent. Por ~ ..plP, the ,..~ 1;---" can have a pore size of
about 0.2 i~ ,h,. or less. In those c~bo l;. -~ -t~ having plurality of layers, one or
10 more layers can have a bdc~ l blf~lri~ pore sl~
The device can include ~1~ n~l layers or P~ t~ e.g., for use as spacers
and/or ~ul~po~ vith respect to the porous n-~l;....~ 10. An e- "pl ,~ ~u~Oll or spacer
layer can be a mesh or screen.
Exemplary porous media 10, inr~ uopho~;c ~ , include those
~1icrlose~ in T"1~ lio~l Publir~tion No. WO 91/17809 and U. S. Patent Nos.
5,126,054 and 5,451,321. In an embo lim~nt ~L ;l~lf SS, S~lbi~t ~ ly alcohol-insoluble,
~ophilic pol~de membranes, such as those ~es-~ ~ ;l~d in U. S. Patent 4,340,479,are suitable. Other suitable porous media include pol~t h,.n~olu~l~lene (PTFE)
membranes, inrblAi~ 0.2 micron PTFE membranes, such as those available from Pall20 Col~l~ion (East Hills, NY) under the name Hydrolon~ PlPE. Other suitable media
include, for ~ntrl~ 0.2 micron PTFE l,.-- ,~h~ fs available from S~ ,o Fl~c~ric
T~ s (Osaka, Japan) under the name Poreflon~. The porous media can col~ e
d and/or ;l~t~ d media.
The h.~ 14 can be fablic~d from any suitable ~ ~,ious ".~t,., ;Zl,
25 preferably a rigid mq~ l, such as any thermoplastic m~tPri~l, which is co".~ ;hle with
the fluid being plocessEA For example, the h.~ can be f~ tp~ from a metal, orfrom a polymer. In an ~ boA;~ n' the h..~ is a p~ ~, preferably a ~ .CpA~e,~
or t~nchl-~Pnt pol~ " such as an acrylic, pol~ l ne, pol~ ~, or a
poly~l~ed resin. Such a h.~ iS easily and ~o~ ally fal~ and allows
30 obsc.~ u of the p~ss~e of the liquid ~ ,ugll the h~
The ~- - r~r~s of the h.,..~ C~ the fluid may be treated or u~ akd. For
lc, the ;,-~f~ s of the ho..~ c~-"~ the fluid may be r~nd~.~d li~luo~hilic for
68478 i CA 02236409 1998-04-30
better ~ ~i.lg. Methods for h~a~hlg the surface of the _uu~ing include but are not
limited to ~ ;on ~.,.rl;.,~ and gas plasma h~
The huusi~ may be co~l~;w~d for ease of use. Por t~'-, the h.J-.~ may
include a bracket or hook for ease of ,--o~ or support during --l-..;n;~ ;on of a
S pd~.~ fluid.
The h...J~inp can be sealed as is known in the art, e.g., via welding and/or an
adhesive. Por e~aInple, first portion 16 and second portion 18 can be bonded or welded
~g. !l.--(, e.g., after fitting lip 19 into groove 29. ~"l.l;l;.~ lly, the porous ,..~ - .. 10
can be sealed within the ho~;~ 14 to achieve CO~ e of use, rapid p~;...;.~p, and
10 ~rli.~ gas cl~A.~e. Suitable ~ ;hn~s for sealing, fitting, and/or bon~ g the
"-~-1;. -" within or to the h.,~.~i~ are known in the art. For e~ let the porousi"~.. 10 can be col~ ~ioll sealed or inte.r~ fit within the huu~ing, or bonded
to the ho!.c;-~. The porous ,..~l;.--,. can be welded to t_e h-.~J~ , e.g., heat welded or
ulh~Lson~cally welded.
In a pl~;f~ d e~b~~ the h()llcin~ 14 is ~l~,~,1 to direct fluid
non-lA~- n;~lly to the fir t surface 50a of the ~le~ r~ 50. For PY~mple, the
housing can include a nipple 22, having a port 23, and the huu~ing can proride for
dil~ g fluid ~.~h~ ;ally pe,~en~ rly to t_e first surface 50a of th-e rlf~g,qcsing
cl~ ..- n The ~o~ g 14 can include an ~l~en~ of ribs, walls or p~;ecLions, or
20 may com~lisf; one or more r.h~n.rl.c, grooves, co~lui~, pass~es, or the like which may
be s~ ,~i~, pqrallf l, curved, radial, spiral, or have a variety of other con~lr~tionc.
Typically, at least one ~ç~ ion faces the first surface 10a and/or faces the second
surface 10b of the porous ~.~f~rl;.l.n 10. The ribs, w. lls or l~uje~lio~s may be used to
define the rllqnnPlc, glOO~.,S, cQ~ul~ , or pqcc~Ps Typically, the huu~ 14 inrhl~lPs
at least one rib, wall, or pl~;f~lion to support andlor po~ ;o~- the porous n~.li.. 10
within the hu -,;~ some emho lin~f .n~i, the hu~ -g inrllldes at least one rib, wall or
pLUj~;~ to i~ro~ the ~ of gas flow, e.g., by ~pol~ g or pGi,i~ning the
porous Illf'-l;ll"~ 10 within the housi,lg while providing cl~ e ~h.~,cn portions of the
first surface 10a and the ho-- si.~ .
Typically, as i~ -, t~ in Figure 2, first portion 16 ;n~ludf s ribs 25 and
ch~nflc 24, which are ~l~f~,.~l~ cQ.~nl~.r ribs ~d C~ e, to allow more erl;ci~nlflow of gas to the gas passa~ .~ 5. The first portion can also have radial rl~an.~Flc 27,
6&478 CA 02236409 1998-04-30
and at least one, more preferably, at least two, ~ ;n"~l ribs such as co.~ ;c ribs 26
and 28. Pigures 2 and 3 also ilhl~t~ rib 26, that plef~ably pO,;I;.?~.c the ,,,P.l;..." 10
with respect to first portion 16.
In the eInbo~limp-nt ill-.~ ~l in Figure 1, the first portion 16 and the second
S portion 18 are sealed to form a first rh~ her 15 and a second ch~ lx 20,
,...p~csi~ lumen or central portion 21. The first and second ch~-..h~-~ can be
similar in volume, or one rh~mhPr can be larger in volume than the other. For
~r , 1~, in some e.llbo~ accol.ling to Figure 1, the ratio of the volume of the
first ~h-...l~ to the second ch~...~ can be in the range of about 1:1 to about 3:1.
In some c mbo~ c, the device 100 can also include a cap or closure, e.g., for
cu~e~mg or sealing port 30. Por ~le, in accol~la~ with any e,ubo~ of the
device 100 a cap can be used to cover port 30 to prevent the entry of gas, and to
u~.,r port 30 to allow gas to exit the device.
The device 100 may be incGl~.?~at~d into a variety of fluid ll~r~. and/or
processil~ S~lllS or sets. Embo~;n~ . of e~el~ t,,~s 500, 501, which are
preferably pale~.~l fluid z.l.,,;n;~l",l;o~ sets, are ill~ ~ in Figures 7 and 8,
Typical embo~l;... 11e of the system 500, 501 include at least one co~ r, more
preferably, at least two co~ 200, 200' for holding the fluid(s) to be lla~r."l.,d,
and one or more co~ that provide fluid c~,.. ~n;~ n ~l~xn the co.~ nf r, thedevice 100, and the ~e~ - of the fluid, e.g., a padent l~C~;Vi~g the !~ r. l~
fluid. As i~ in Pigure 8, the system 501 can also include at least one filter 300
for filttori~ the fluid to be l . ~ r. . . ~d.
The co.d~;nf . 200, 200' which can be used in the system can be co~~ ;h~d of
25 any ,..;~l- ;Al ct~ ;hle with the fluidto be !~ r~ d. A wide variety of suitable
co.-1~ are already known in the art. Typically, co"t~;n ~ 200, 200' cc....~ ,s a
flexible ~--~1; - ;al, for eA~lc, polyvinyl chloride (PVC). An f~Yf ~ / CO-~ f~ iS a
flexible bag, e.g., as is used for ho~ ~ blood or blood co~n~ and/or saline.
~lh."~ , the co-l1;~ f .. may be CO~ OS~ of a non-flexible material. It is ;~r ~
30 that the i~ iull should not be limited by the type or co~ o;,;l;o~ of the co..~;~ ~ being
employed.
As with the co~ ;n~ ~, the co~.~h~ 201, 210, 219, 220, and 230 can be
6 ~78 CA 02236409 1998-04-30
constructed of any mqtPriq-l that is co...p-~;ble with the fluid(s) to be Ll~f~ L
Typically, the co..~]~ COlll~l~ n.,Ai~le mqt~riql A pl~,fe.l~,d mqt~liql is PVC, for
el ~n~l k~. As used herein, the coll-lui~ are any tubing or means which provide fluid
CQ-----~n;~-l;O~ b~,h.e-,n the various COlul~v~ ~ of the a-l~ n ~t.
At least one flow control device 400, 400' such as a cl. mp (i~ l---l;"~, for
e~...plf-, a roller clamp), seal, ~lopcorL, valve, ~la~f~. leg closure, or the lil~e, _ay be
~cs~; ~ with at least one of the co~i~ in order to f:~~ilitqt~ a desired Ç~ , i.e.,
to open, close, and/or m~~ e the desired flow of the fluid (e.g., pa~n~.~l fluid)
and/or gas. In some e.llbo~1;n.Fn~, particularly for some of the ~ ..l~l;n.. .l~ that
10 include ~ t~ 8 fluid to a patient, the flow control device 400' dow~lL.,alu of the
device 100 co...l.. ;.~c a roller clamp to control the flow rate.
As i~ al~ in Figure 8, the system 501 can also include at least one filter 300,
to filter the fluid to be ll~f~ ,d. A variety of filters are ~LIi~ble for use in the
system, e.g., IV filters, e.g., for ~.l."in;.~t~.. ;.,~ drugs and/or ..~l. ;F ~I~; and blood filters,
15 inrl in~ Clvaggf~ga~ filters and/or leukocyte depletion filters. Typically, the filter
con~l..;.C~s a filter assembly, inrlllr~ a k.~ ing having an inlet and an outlet and
providing a fluid flow path ~,en the inlet and the outlet, and a porous filter ".~1;~
for filtP~in~ the fluid di~oscd ~e~._.,n the inlet and the outlet and across the fluid flow
path.
In some c.l~bo~ , inrhlrlin~ those embo~ that include at least one
filter, the system may include at least one ~ lrlifff)nql vent c~.",l.. ;~in~ a gas inlet and/or
gas outlet, wLc.~ the vent inrhllies a porous "~1;---,- ~ui~ble for pa~i~ gas
ll,c~lluvu~. For ~ le, Figure 8 i~ s an ~lubodi~,~ of a syste~n 501
inrhl~fli~ a vent 101 such ~ a g~ outlet i~.~osed ~t..~ , and in fluid co~ ni~-l;
with, filter 30C) and device 100.
As noted earlier, the sys~em may have a~lfl;l;~ l c~..l~n~-nl~ such as, but not
limited to, conn~v~ ;l;on~l co..l;.;..- ~ ecLion ports, and ~d~ n~l vents such ~g~ inlets and/or gas outlets.
~ ubof~ of a ~--I Il-f~ acco~lin to the ill~.,~ion include lorv~ the device
30 in a fluid flow path ~t~,e~l a source of fluid, e.g., a contai~, and the ;nr nfl~d
de,l;n~ Jn of the fluid, e.g., a patient, and l.,.. ~ ~.;n~ the fluid lu~u~ the device.
For eYD~ le, l~f ~ - ;-.~ to the e ~- ,"~1D~ eInbo~1im~nt ill--~ r ~i in Figure 7, fluid flow
68478 CA 02236409 1998-04-30
control devices 400, 400' such as clamps u~ Le&ll and dOw~~ of the device 100are typically closed initially, and then the flow con~rol device u~ ,alu of device 100 is
opened, to allow fluid to enter the h.~ ;r~. Since the flow control device dow~
of the device 100 I.,~ai~s closed, gas (e.g., gas ~ ~~1 into the hv~ by liquid
S pa~siu~ (JU~ the CQ~ (S~) passes through the vent 3 as the device fills with liquid.
After the device fills to the desired level, the flow control device d~l.~ of
device 100 is open~ and the fluid is p~sed to the desired ~lin~t;.Jn In those
Fn~ eill fluid is passed at a high rate ~ vu~ the device 100, e.g., wl~m
the patient ~ s one or more units of blood p~lu~ at a flow rate of at least about
100 cubic c~ lt;n.~r ~.~ (cc's) per minlltje, more ~l~,fi,~abl~, at least about 300 cc per
minll~ even more p~f~,.ably, at least about 400 cc per milmte, the fluid passmg
11LVU~ the (i~g~ss;n~ el~ 50 is ~;~ as smaller bubbles coqlPs~e into larger
bubbles that rise in the lumen or central portion 21 of the device. In an emho~limPnt,
some of the coqlpsce~ bubbles pass through the vent 3.
In acc.l~n~e with pl~fe 1~,1 embo~ t~ of a method accof~i~ to the
invention, the device allows the O~ atOl to observe fluid flow even at the higher flow
rates. For e~n~ the O~aLOl can observe drops of liquid ~ -~t - ;.~ the device, or a
stream of liquid f~ the device. Thus, the device does not "overf~" during use.
Mol~o~ , while the device is s~it~ble for ~.h..;..;-~in~ fluid at high flow rates, it is
20 also suitable for use at lower flow rates, and thus can be used during the entire fluid
a~l~n;~ aLion p~ocol. The device should be co~ u~ to lla~r~,~ the fluid quic3~1y.
In a p~,f~ d e ..I~l;...- ~-~ for use with biological fluid, the device has a small hold up
volume, e.g., about 15 cc or less.
Using Pigures 1 and 7 (ill..~ an e .ubo~l;...- ~~t of the device 100 and system
25 500, ~w~e.,Li~ ), for l.,f. .~,~ce, fluid is passed, e.g.; using a pump or by gravity, from
co.~ f ~ 200 l~ u~ at least one conduit to device 100, ~vhile the flow control device
400' d~w~lL~ of device 100 is closed. Liquid and gas enter the h....~ o 14 via inlet
1. l?~,f~,.ably, device 100 (~igure 1) inrll~es â nipple 22 and a port 23, and fluid
passes into lumen or central portion 21, and the fluid is dil~.,t~d non~ ;ally (e.g.,
30 ~ b~ lly pc~ rly) to the first surface 50a of the ~k'~ el~ f .lt 50. If
desired, fluid can be d ~ ,t~ into the ce~al portion 21 in the form of droplets.Pluid f,.~t..;.~ the lumen or cen~ portion 21 c~ t ~1~; the ~ega~ elo-nf-n~ 50
12
68478 CA 02236409 1998-04-30
in the second ch~mher 20. Since the fluid flow path dow~~ of the device 100
le~a~c closed, the device acts as a l ~ ..~rùi~ ~ second ch~ ~he~ 20 fills with liquid. As
the second ~.h---.l~, 20 and rlf'5~ ClP~ p~ 50 fill with liquid, gas is displaced. Some
of this gas is vented from the device, i.e., the gas passes from the i l~.ior of the
5 h.~ ;n~ along a gas flow path lhL~u~ porous ".P.l;~..n 10 via surface 10b and surface
10a, and lll~u~ port 4 and gas pa~,_~.~ 5 to the t~ ;0~ of the h.,..c;n~ In those
e.ubo~ r~ wL.~m the h.,..~ s ribs and ~.h~nn~lc~ e.g., ribs 25 and ch~ lc
24 and 27 as ill~ rl in Figure 2, gas pacses along ch~ c 24 and 27 through port 4
to gas p~c~ ..~ 5 to more e r~ vent the device.
Second ch~ hc~ 20 (shown in Figure 1) co.~ s to fill with liquid, and
e~ally, the level of liquid will reach surface 10b of porous ."~1;~" 10. Once liquid
covers the surface 10b, gas flow lllUugll the vent 3 stops, wi lluul liquid s~ r ..,~;ally
pasi,iug t~rough the ~, ~1;---" 10. Once the gas flow stops, the device 100 is filled to the
desired level.
~ some embo~;.. ~ .l i, gas flow stops when the device 100 is about 2/3 filled
with liquid. Illu~ ivcly, when passing a red blood cell-co~ fluid such as packcd
red cells (PRC) or whole blood into the device, the device has a total Ca~a~ of, for
e~ample, about 15 cc, and gas flow stops when the device co~i~s about 10 cc of
liquid. In a~ cmbo~ when passing a plat~let co~t~ini~g fluid such as platelet
20 con~F~ ~ (PC) into the device 100, the device has a total Cd~ily of, for e~lc,
about 9 cc, and gas flow stops when the device cont~inc about 6 cc of liquid.
Once the device is filled, the ~ "~ of the sy-stem can be prim~, and the
Liquid can be del;~ ,d as desired. For e~ , using Figure 7 for ~f~ ce, the flow
control device 400' duw~ll~,~ ûf device 100 (e.g., a flow control device such as a
25 roller clamp) can be opened, and the fluid can be ~ ~d to a patient. Typically, a
volume of gas will be present in the in~erior of the h....~ 14, and the liquid level will
re ain at the desired level, or less, during ~.n;..;.~h,.~;ol~
As noted earlier, it may be nFce~ to ~I...;n;~h ( fluid at a high flow rate
during at least a portion of the patient treatment or ~l",;~ h ~;on ~lotûcol. Such a
30 prot~col may include ~ g stored blood or blood coll~l~n~ i (e.g., to the pa~ l'S
body t~ ) and pdSS~ the ~.alll,ed fluid through the device 100. As the blood
is ~ 1, gas is l~,ledscd in~o the blood. While the volume of gas l~,l~d into the
68478 CA 02236409 1998-04-30
blood is SOll~ .haLul~p ~li~;~ble, the ~cg~c.ci,~ 50 in device 100 provides for
reliably coqlPsci~ smaller gas l,~l~les into large bubbles, . nd the larger ~bbles rise in
the lumen 21 of the device. Thus, once the system is primed, the fluid pa~ g through
second surface 50b of ~le~~~in~ elP~ .n 50 and exiting the device 100 through outlet 2
5 is s~ ly de$~sed Typically, the ope.ator of the system will be able to obs.,~c
fluid flow, e.g., ~ plet~ of liquid, or a liquid stream er~ering the device during the
..;ni~ plo~ocol.
In an e ..hol;n.- n~, after q,~l-,-;n;.~ n of the fluid is ~ lly completed, someof the liquid ~t~i~ in the device can be ~ ;n;cr ~,d to the patient. For example, gas
can be allowed to enter the device 100 through port 30 (Figures 1 and 6), and some of
the liquid l~ ~i~ in the device can be passed to the patient. In those embo~l;... ,l~
wll~ port 30 was capped after the ini~l ~,nti~g of the device 100, the O~ Ol of
the system will uL~u~r or uncap the port to l~O~ some of the fluid l-,~i~ in thedevice 100. After allowing gas to enter the device, the op~- -tOI can m~ml~lly stop the
15 flow of liquid before g~ can reach the patient.
If desired, the device 100 can initially be filled to a desired level with one fluid,
e.g., a non-biological fluid such as saline, and after the ~~evice vents gas and fills with
this liquid, the liquid is a~ ed and then a second fluid, e.g., a biological fluid that
is co~ ,.Lible with the non-biological fluid, is passed through the device and
20 ~.l...;n;~ d For c~ , using the system 500 shown i~ Figure 7 for l.,f~ cc, a
p~,~,al fluid such as saline can be passed from con~i~r 200 to device 100, and gas
is ventcd, and then the fluid is ~.l...;n;~ ,d as ~.~s~ ;l~d above. Sul~se.lu."~ n~ f,r
pd~ l fluid, e.g, a biological fluid such as packed red blood cells, is passed from
co.~1~;nf ~ 200' ~ uugh the device 100 and then to the patient in a genP~lly similar
25 ,.,~nnf ~ as ~ r. ;l).3~i with respect to the first fluid. In a pl.,f. ,l~d embo~ , the
Opf~d~O~ of the system can observe fluid flow through the device with each of the first
and second fluids during î-l.";ni.~l...l;on
As noted earlier, and as shown in Figure 8, the system 501 can also in~ p a
filter 300 such as a lcuLuc~lc ~lf.~letion f~ter. For ~ plfe~cQl~t~;n , 200' co.n~ a
30 lcu~ c-co--~;--;-.~ biological fluid such as blood or a blood CO~ lf~ll, and the
l~;olo~ l fluid can be ~l...in;.~l as following. Using Figure 8 for l~,f. ,~,~ce, the
flow control devices 400, 400' are typically initially closed, and the flow control device
14
6~78 CA 02236409 1998-04-30
400 ~l~n the co~ cr of leu~ cG.~ ;n;.~ biological fluid and the filter 300 is
opened. If desired, the co.nA~I~f,~ of biological fluid may be s~ to more err~ r~ y
prime the filter 300. Gas displaced during the p. ;...;n~ of the filter 300 is passed
through co~uil 219 ahead of the biological fluid, and passed lL~u~ the vent 101. If
5 desired, the vent 101 can p~v~ide for sep~ gas from the biological fluid flow path.
After gas is passed 1~ U~ the vent 101, the flow control device 400 ~s~i~h ~l with
c~ h~;l 220 is openP~l and the biological fluid, along with some air ~plac~ fromco~L ~o, enters the device 100.
Device 100 vents g~ and fills with liquid ~ ~ ~l ;l~d earlia. After the device
10 a~lu~ l;r~lly ven~i and fills to a desired level, the flow co~ol device 400' duw~ll~
of device 100 can be opened, the rest of the system can be primPd and the liquid can be
;~-1.";";.~ip ~ to the patient.
In a v~n~ n of the t~b~l~n- ~~ of the ~A ~s ill..~l."~ in Figures 7 and 8,
the device 100 can include ~p . Z~h- inlets for the ~rr~ ~nL par~ fluids. Por
15 example, the embodiment of the device 100 ill~ d in Figure 6 can be utilized in
such s~L~s. The ~:~tL~S can be o~.d~d as gen~lly ~sçrih~l above, with the
~c~lir~ ion that one fluid enters the device via inlet 1, and the other fluid enters the
device via inlet 1'.
In a variation of the device ill--~l.,t,~d in Figure 1, a conduit is co...~r-c~ed to port
30, and the device laclcs a porous ",~li~n, 10 in the h.. c;n~ 14. The end of the co~.huL
not co..,-Fc~l to the port 30 is typically closed, or colln~eled to another co~ t of
the system, such that gas P .h ~ ;.~ the device is passed from the h.)--~i~ through the port
30 and into the coldluiL, wL~lem the conduit plo~ides a bubble trap.
All of the lefe.e~ces cited herein, inf~ pllh~ qtionc, p~ntc, and patent
appli~ ionc are hereby i~col~lat~d in their e~i,.,~es by l~,f~ ce.
While the invention has been ~e~ d in some detail by way of il~ ................ and
e~k, it should be ~ tood that the iu~ ~ioll is ~;cep~ible to various
mo~lifi~ 7n.c and ~ n ';ve forms, and is not ~i~ 't~;~ to the ~pec;fi~ e,l.bo~ set
forth. It should be ~n~ ~o(l that these Sp~;lir P...~1;.n. ~ are not ;nh ~fled to limit
30 the i l~_~ioQ but, on the cO~L,~, the intPntiQn is to cover all mn~ ,.l ;on.c,
e~uivalents, and ~l~ ~" ~ s falling within the spirit and scope of the i~ ~io~.
